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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sunglasses (Non-Prescription Including Photosensitive)
510(k) Number K902322
Device Name SOLAR-MATES SUNGLASSES, BONJOUR EYEWEAR
Applicant
Nevitt Sales Corp.
9 Neil Ct.
Oceanside,  NY  11572
Applicant Contact STEPHEN NEVITT
Correspondent
Nevitt Sales Corp.
9 Neil Ct.
Oceanside,  NY  11572
Correspondent Contact STEPHEN NEVITT
Regulation Number886.5850
Classification Product Code
HQY  
Date Received05/24/1990
Decision Date 07/05/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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